Pancreatic Fistula
Conditions
Keywords
postoperative pancreatic fistula, soft and hard pancreas
Brief summary
The purpose of this study is to assess the value of preoperative objective modalities such as endoscopic ultrasound elastography and magnet resonance imaging in predicting development of postoperative pancreatic fistula in patients undergoing pancreatic surgery for benign or malignant disease.
Detailed description
One of the most generally accepted causes of postoperative pancreatic fistula (POPF) is soft texture of the pancreas. The stiffness of organs depends on histologic features such as content of fat, fibrotic tissue and micro vascular structures. Yet, pancreatic stiffness was evaluated only subjectively. Endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) may allow objective quantification of pancreatic stiffness prior to surgery. Endoscopic ultrasound elastography (EUE) is based on real-time Doppler technology. Image colors are derived from vibration patterns which depend on the stiffness of a specific region of the investigated organ. The retrieved images could be converted into numeric matrix using a specially designed program. Magnetic resonance imaging (MRI) is a non-invasive method for quantitatively assessing the mechanical properties of tissues based on fat tissue content. In this trial the investigators will assess at first the value of EUE and MRI in predicting development of postoperative pancreatic fistula and in a next step the value EUE and MRI as an objective method in prediction of pancreatic stiffness.
Interventions
PROCEDUREPancreatic Resection
Endoscopic ultrasound elastography, intraoperative ultrasound elastography and magnet resonance imaging to asses pancreatic stiffness prior to pancreatic resection
Sponsors
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (more than 18 years) with resectable pancreatic lesion(s)
Exclusion criteria
* Total pancreatectomy * Unresectable pancreatic lesion(s) * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POPF rate (in %) as defined by the International Study Group on Pancreatic Fistula (ISGPF) in the soft versus hard pancreas group based on the median EUE stiffness measurements generated by values derived from hue histograms. | within the 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pearson correlation coefficient between preoperative EUE measurements of pancreatic stiffness generated by values derived from hue histograms with intra-operative ultrasound elastography measurements generated by values derived from hue histograms. | within the 30 days after surgery | — |
| Postoperative pancreatic fistula rate (in %) as defined by the ISGPF in the soft versus hard pancreas group based on the median MRI fat measurement (in %) on histology. | within the 30 days after surgery | — |
| Pearson correlation coefficient between preoperative MRI measurements of pancreatic fat (in %) with the fat content (in %) of the resected specimen on histology. | within the 30 days after surgery | — |
| Pearson correlation coefficient between preoperative EUE measurements of pancreatic stiffness generated by values derived from hue histograms with the fat content (in %) of the resected specimen on histology. | within the 30 days after surgery | — |
| Pearson correlation coefficient between the two surgeons assessing pancreatic stiffness intraoperatively. | within the 30 days after surgery | — |
| Intraclass correlation coefficient of the all measurements derived from EUE, IUE, MRI, surgeons assessment and histology. | within the 30 days after surgery | within the 30 days after surgery |
| Postoperative pancreatic fistula rate (in %) as defined by the ISGPF in the soft versus hard pancreas group based on the surgeons assessment of stiffness on a visual analogue scale from soft (0) to hard (10) intraoperatively. | within the 30 days after surgery | — |
Countries
Switzerland
Contacts
Primary ContactHenrik Petrowsky, Prof, MD
Backup ContactDilmurodjon Eshmuminov, MD
Outcome results
None listed